AQUACEL® Ag Surgical Cover Dressing (SCD)

AQUACEL Ag Surgical Cover
Dressing (SCD)
®
Value Analysis Committee
Product Information Kit
The right dressing can make a difference
Aquacel® Ag SCD reduces periprosthetic joint infection (PJI)
and improves patient outcomes
PJI following total joint arthroplasty (TJA) is one of the most devastating
postsurgical complications and continues to be a challenge for many
healthcare organizations as the demand for TJA rises.1,2
PJI treatment often requires prolonged hospital stays, intravenous (IV)
antibiotics, and additional surgical procedures. In addition, wound infection
contributes to delayed healing, increasing the burden to patients and the
cost of their healthcare.3 Although much work has been done to guide clinical
practice in the prevention and treatment of PJI, wound management is often
overlooked. Dressing technology plays a vital role in preventing PJI following
TJA and should be given due attention.4
AQUACEL® Ag SCD is an occlusive, skin-friendly surgical dressing infused with
ionized silver for greater antimicrobial protection. The Hydrofiber® technology
employed in AQUACEL® Ag SCD allows it to micro-contour to the wound
bed—minimizing voids where bacteria can grow while maintaining the optimum
moisture balance for healing. AQUACEL® Ag SCD is flexible, absorbent, and
waterproof, so patients can shower shortly after the dressing is properly applied.
Over the next 18 years,
the demand for primary total hip
arthroplasty (THA) is estimated to grow
by 174%, and the demand for primary
total knee arthroplasty (TKA) by 673%
With the projected rise in TJA over the next 18 years, an increased emphasis
on patient satisfaction, strict monitoring of RSCRs and RSRRs, and the onset of
VBP, improving postoperative surgical dressings is a simple and cost-effective
measure that can have a profound impact on the financial success of acute
care facilities.
Overview of In-Patient Quality Reporting
•N
ational Quality Forum (NQF: http://www.qualityforum.org/qps/) measure
#1550 estimates hospital RSCRs following elective primary THA and TKA,
including wound infection and PJIs9
•N
QF measure #1551 estimates hospitals’ 30-day all-cause RSRRs
following elective primary THA and TKA9
Value-Based Purchasing: Changing the way hospitals are paid for services
to Medicare beneficiaries7a
• National pay-for-performance system10
•V
BP-eligible hospitals are scored based on achievement and improvement
in clinical measures and patient satisfaction
• Directly impacts incentive payments for acute care hospitals
• 2% penalty applied if IQR is not submitted
5
Recent clinical studies confirm that use of AQUACEL® Ag SCD significantly
reduces the incidence of PJI after TJA6 and increases patient satisfaction.4
These are important outcomes to consider given the demand for more stringent
reporting from the Centers for Medicare and Medicaid Services (CMS) and the
impact that reporting has on Hospital Compare (http://www.hospitalcompare.
hhs.gov) and the Value-Based Purchasing (VBP) Program.7a,b
New initiatives, including the Hospital Consumer Assessment of Healthcare
Providers and Systems (HCAHPS: http://www.hcahpsonline.org) survey8 and
in-patient quality reporting (IQR) of hospital risk-standardized complication
and readmission rates (RSCRs and RSRRs) following elective primary THA
and TKA,9 have been implemented as new standards for tracking patient
satisfaction and quality of care. Adherence to these reporting guidelines will
directly affect Medicare payments and the reputations of healthcare facilities.
2
Weighted Value of VBP Domains for CMS Acute Care Hospital Evaluation7a
Clinical Process
Clinical Process-ofof Care Domain
Care Domain
Based on evaluation of
12 clinical process-of-care
measures*
70%
30%
Patient
Experience
Patient
Experienceof Care Domain
of-Care Domain
Based on HCAHPS survey of
8 patient experience-of-care
dimensions*
*A detailed listing of the 12 clinical process-of-care measures and 8 patient experience-of-care dimensions is available at:
1) http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/hospital-value-based-purchasing/index.html,
2) http://www.healthcare.gov/news/factsheets/2011/04/valuebasedpurchasing04292011b.html, and
3) http://www.hcahpsoneline.org/home.aspx
3
Product Overview
Product Illustration
AQUACEL® Ag SCD: Not all silver dressings are created equal
Combining flexible, skin-friendly hydrocolloid technology; patented, microcontouring Hydrofiber® technology with ionic silver; and waterproof polyurethane
film, AQUACEL® Ag SCD helps improve outcomes by creating an optimum
healing environment and providing broad-spectrum antimicrobial activity.
Comfortable & Flexible
Why purchase AQUACEL® Ag SCD for an orthopedic surgical unit?
To Reduce Incidence of PJI
New research supports that
AQUACEL® Ag SCD can reduce
the incidence of PJI by as much
as 76% compared to standard
gauze dressing6
To Improve Patient Outcomes
Reducing infection decreases
the need for lengthy hospital
stays, treating infections with
IV antibiotics, and revision
surgeries. Aquacel® Ag SCD
also promotes healing and
reduces the average surgical
dressing wear time4
To Reduce Costs
Absorbent & Antimicrobial
Treating PJI is one of the
most resource-consumptive
procedures in orthopedic surgery
with costs as high as $100,000
per case.11-13 Additionally, new
CMS guidelines limit and/or
eliminate reimbursement
for hospital-acquired infections
Waterproof
What are the competitive advantages of implementing
AQUACEL® Ag SCD?
Antimicrobial Protection
Hydrofiber® technology with
ionic silver micro-contours to the
wound bed—providing sustained
antimicrobial activity for up to
7 days*14-16
Flexible and Skin-Friendly
Protects periwound skin by
helping reduce risk of
maceration and blistering;
allows for pain-free removal
Waterproof
Polyurethane film provides a
waterproof barrier that allows
patients to shower after surgery
Features
Benefits
Hydrocolloid technology
Provides comfort and flexibility
Hydrofiber® technology
Micro-contours to wound bed, eliminating voids where bacteria can
grow; locks in wound exudate and removes it from wound bed*14-16
Ionic silver infusion
Releases ionic silver in a controlled manner, providing sustained
antimicrobial activity for up to 7 days*14-16
Polyurethane film
Creates a waterproof barrier that helps prevent viral and
bacterial infection*14
*As demonstrated in vitro
In one of the largest clinical studies to date,
Aquacel Ag SCD was proven to reduce
the incidence of PJI by as much as 76%
compared with standard gauze dressing6
4
*As demonstrated in vitro
AQUACEL Ag SCD with ionic silver is
indicated for moderate to high exuding
wounds that are infected or at risk of
infection
®
5
510(k) Clearance
6
7
Clinical Information
New research indicates that
AQUACEL Ag SCD plays an important
role in reducing the incidence of PJI
and improving the patient experience
®
The AQUACEL® Ag Surgical Dressing With Ionic Silver Reduces the Rate
of Acute Periprosthetic Joint Infection Following Total Joint Arthroplasty6
Cai J, Karam J, Parvizi J, Smith EB, Sharkey PF
Methodology
This retrospective study was conducted at Philadelphia’s Rothman Institute
by performing chart reviews to compare the overall incidence of PJI in
2 groups of patients who had undergone TJA. The study group of 903 patients
received an AQUACEL® Ag SCD (applied in sterile conditions in the operating
room) that remained in place for 5 days. The control group of 875 patients
received a standard dressing of sterile gauze applied over the incision site and
secured with adhesive tape in the operating room.
Results
AQUACEL® Ag SCD reduced the incidence of PJI by 76%. The study group
had an incidence of acute PJI of 0.4% (4/903) compared with the control
group treated with standard dressing, which had a 1.7% (15/875) incidence
of acute PJI.
Conclusion
According to Dr. Peter Sharkey, “the systematic use of AQUACEL® Ag SCD would be an effective measure to
prevent the occurrence of acute PJI following TJA.”
8
Real-world clinical experience reveals benefits of Aquacel® Ag SCD
compared with tape and gauze dressing4
Overview
As part of an initiative to improve infection control protocols at NorthShore
University HealthSystem, Dr. Kudrna and colleagues assessed the clinical efficacy
of Aquacel® Ag SCD to reduce postsurgical complications compared with
standard surgical dressing.
Methodology
A group of 482 patients undergoing primary THA who received AQUACEL® Ag SCD
were compared to a retrospective matched cohort of 482 patients who received
a standard surgical dressing consisting of gauze and Elastoplast® tape. The rates
of blistering, number of dressing changes, and overall incidence of surgical-site
infections (SSIs) were carefully reviewed for both groups.
Results
No SSIs occurred in the AQUACEL® Ag SCD group (0%) compared with a 1.6%
incidence of SSIs in the standard dressing group. A marked reduction in surgicalsite blistering was also achieved in the AQUACEL® Ag SCD group (0.2% vs 11.4%
in the standard dressing group). Additionally, the number of dressing changes
(2.2 for AQUACEL® Ag SCD vs 5.1 for standard dressing) as well as the average
wear time of the surgical dressing to wound healing (9.3 days for AQUACEL® Ag SCD
vs 13.4 days for standard dressing) were considerably lower in the
AQUACEL® Ag SCD group.
Conclusion
Dr. James Kudrna and his team of researchers found that “…the
use of AQUACEL® Ag Surgical Dressing compared to a standard
surgical dressing…diminished the rate of wound complications,
blister formation, and surgical site infections…”
9
Competitive Product
Comparison
Interim analysis of a new study indicates that Aquacel® Ag SCD reduces
wound complications and improves patient satisfaction4
Overview
In an ongoing prospective randomized study, Dr. Springer and associates
are evaluating the use of Aquacel® Ag SCD compared to a tape-and-gauze
dressing (Primapore™ ) used as the current standard surgical dressing at
OrthoCarolina.
Competitive Product Overview
In vitro studies have shown that AQUACEL® Ag SCD offers distinct advantages
over other silver-impregnated dressings. The Hydrofiber ® technology locks in
wound exudate and safely removes it from the wound bed and surrounding area.14
This protects those surfaces from potential maceration. Hydrofiber ® transforms
into a clear, soft gel once it absorbs fluid, allowing it to micro-contour to the
wound bed and fill “dead space” where bacteria can proliferate.17 This gelling
feature also allows AQUACEL® Ag SCD to respond effectively to different wound
conditions, maintaining a favorable wound-healing environment and providing
increased silver ion availability “on demand.” 14
Methodology
The study involves 150 patients undergoing THA and 150 undergoing TKA
that are being randomized prospectively to 1 of the 2 surgical dressings
(Aquacel® Ag SCD or Primapore). Outcomes for the study include wound
complications, number of dressing changes, blister rates, overall patient and
nursing satisfaction, and an economic analysis of the cost-effectiveness of
the surgical dressings.
Results
Although the study continues, interim analysis of the first 150 patients that
underwent TKA demonstrated fewer dressing changes and a significant (P<.02)
reduction in overall wound complications associated with Aquacel® Ag SCD
compared with Primapore. In addition, no patients in the Aquacel® Ag SCD
group required additional surgical procedures, whereas 2 patients receiving the
Primapore did. Patient satisfaction, defined as patients’ perception of hygiene,
sterility, and comfort, was also more favorable toward Aquacel® Ag SCD
than Primapore.
Product Comparison—A Qualitative Assessment of Key Product Attributes
AQUACEL® Ag
SCD
Mepilex® Ag
Border
Silverlon®
Acticoat® 7
Silver-impregnated
✔
✔
✔
✔
Sustains antimicrobial activity
for up to 7 days
✔
✔
✔
✔
Waterproof
✔
✔
Fully occlusive
✔
Hydrofiber® technology
✔
Micro-contours to wound bed, locking
in fluid and sequestering bacteria
✔
Responds to changing wound
conditions by forming a cohesive gel
✔
Proven to reduce PJI by 76% vs
standard dressing6
✔
✔
In vitro studies have demonstrated that
Aquacel Ag SCD conforms to a simulated
wound surface better than Meplilex Ag
dressing, providing greater control over the
growth and spread of bacteria under the
dressing17-19
10
11
AQUACEL® Ag SCD
Available Sizes and Product Order Codes
SKU
UPC
Dressing Size
For Incisions Up to
Dressings per Box
412009
76845511116
3.5” x 3.75”
(9cm x 9.5cm)
1.5”
(4cm)
10
412010
76845511119
3.5” x 6”
(9cm x 15cm)
3.5”
(9cm)
10
412011
76845511122
3.5” x 9.75”
(9cm x 24.8cm)
6.5”
(17cm)
10
420670
768455125111
3.5” x 12”
(9cm x 30cm)
8.5”
(22cm)
10
412012
76845511125
3.5” x 13.75”
(9cm x 34.9cm)
10.5”
(27cm)
10
Ordering Information
Convatec Products Website:www.convatec.com
Customer Service:
1-800-422-8811
References: 1. Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty.
2012;27:61-65 e61. 2. Bongartz T, Halligan CS, Osmon DR, et al. Incidence and risk factors of prosthetic joint infection after total hip or knee replacement in
patients with rheumatoid arthritis. Arthritis Rheum. 2008;59:1713-1720. 3. Drew P, Posnett J, Rusling L. The cost of wound care for a local population in England.
Int Wound J. 2007;4:149-155. 4. Wound complications and deep periprosthetic infection after total joint arthroplasty. The role of surgical dressing? White Paper.
2012. Data on file, Convatec. 5. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from
2005 to 2030. J Bone Joint Surg Am. 2007;89:780-785. 6. Cai J, Karam JA, Parvizi J, Smith EB, Sharkey PF. The AQUACEL® Ag surgical dressing with ionic silver
reduces the rate of acute periprosthetic joint infection following total joint arthroplasty. Poster presented at: 22nd Annual Meeting of the American Association
of Hip and Knee Surgeons; November 2-4, 2012; Dallas, TX. 7a. CMS issues final rule for first year of hospital value-based purchasing program. Centers
for Medicare and Medicaid Services. http://www.cms.gov/apps/media/press/factsheet.asp?Counter=3947. Accessed on October 16, 2012. 7b. Frequently
Asked Questions Hospital Value-Based Purchasing Program. Centers for Medicare and Medicaid Services. http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/hospital-value-based-purchasing/downloads/HVBPFAQ022812.pdf. Accessed on October 16, 2012. 8. The HCAHPS Survey
– Frequently Asked Questions. Centers for Medicare and Medicaid Services. http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/
HospitalQualityInits/downloads/HospitalHCAHPSFactSheet201007.pdf. Accessed on October 16, 2012. 9. Hospital-level Risk-Standardized Complication Rates
following Elective Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). Yale New Haven Health Services Corporation/Center for Outcomes Research
and Evaluation (YNHHSC/CORE). http://www.qualitynet.org. Accessed on October 16, 2012. 10. What makes a positive patient experience? IHI explores how to
improve a patient’s time in the hospital. Institute for Healthcare Improvement. http://www.ihi.org/knowledge/pages/publications/whatmakespositiveptexperience.
aspx. Accessed on October 16, 2012. 11. Parvizi J, Pawasarat IM, Azzam KA, Joshi A, Hansen EN, Bozic KJ. Periprosthetic joint infection: the economic impact
of methicillin-resistant infections. J Arthroplasty. 2010;25:103-107. 12. de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site
infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009;37:387-397. 13. Lavernia C, Lee DJ, Hernandez VH. The
increasing financial burden of knee revision surgery in the United States. Clin Orthop Relat Res. 2006;446:221-226. 14. Jones SA, Bowler PG, Walker M, Parsons
D. Controlling wound bioburden with a novel silver-containing Hydrofiber dressing. Wound Repair Regen. 2004;12:288-294 15. Bowler PG, Jones SA, Walker M,
Parsons D. Microbicidal properties of a silver-containing hydrofiber dressing against a variety of burn wound pathogens. J Burn Care Rehabili. 2004;25:192-196.
16. Bowler PG. Progression toward healing: wound infection and the role of an advanced silver-containing Hydrofiber dressing. Ostomy Wound Manage. 2003;49:2-5.
17. Antimicrobial activity of silver-containing wound dressings using a shallow wound microbial model. Scientific Background Report WHR13307 MA143. 2010,
Data on File, ConvaTec, Skillman NJ. 18. The antimicrobial activity of silver-containing wound dressings on a simulated colonized wound surface. Scientific
Background Report. WHR13415 MA162. 2011, Data on File, ConvaTec, Skillman NJ. 19. Observed antimicrobial activity of Mepilex® Border Ag dressing using
two in vitro models. Scientific Background Report. WHR13405 MA160. 2011, Data on File, ConvaTec, Skillman NJ.
To find out more about AQUACEL® Ag Surgical Cover Dressings,
visit www.convatec.com or call 1-800-422-8811.
AQUACEL and Hydrofiber are registered trademarks of ConvaTec Inc.
All other trademarks are property of their respective owners.
© 2012 ConvaTec Inc. AP-013291-US

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